Department of Health and Human Services April 29, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with our regulations after we revoked specific requirements pertaining to the use of partially hydrogenated oils in certain foods or as a direct or indirect food substance.
Determination That FLUDARABINE PHOSPHATE Injection, 50 Milligrams/2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that FLUDARABINE PHOSPHATE Injection, 50 milligrams (mg)/2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Food Additives Permitted in Feed and Drinking Water of Animals; Condensed, Extracted Glutamic Acid Fermentation Product
The Food and Drug Administration (FDA) is amending the food additive regulations to update the production organism Corynebacterium lilium that has been scientifically reclassified to Corynebacterium glutamicum. This action is being taken to improve the accuracy and clarity of the regulations.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve a revision of the currently approved information collection project: "The AHRQ Safety Program for Telemedicine: Improving the Diagnostic Process and Improving Antibiotic Use." In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.
Meeting of the Healthcare Infection Control Practices Advisory Committee
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by the number of audio and web conference lines (500 audio and web conference lines are available). Time will be available for public comment. Registration is required.
Meeting of the Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). This meeting is open to the public. The meeting will be webcast live via the World Wide Web.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application 761326 for NNC0148-0287 Injection (Insulin Icodec)
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in New Drug Applications and Abbreviated New Drug Applications; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling." This guidance is intended to assist new drug application (NDA) and abbreviated new drug application (ANDA) applicants in submitting an accurate and complete composition statement in their applications and corresponding statement of ingredients in the labeling, when applicable. This guidance describes best practices for writing the composition statement and corresponding statement of ingredients in labeling. This guidance recommends how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as ensuring product labels are written clearly.
Medicare Program; Application by The Compliance Team (TCT) for Continued CMS Approval of its Home Infusion Therapy (HIT) Accreditation Program
This notice acknowledges the receipt of an application from The Compliance Team (TCT) for continued approval by the Centers for Medicare & Medicaid Services (CMS) of TCT's national accrediting organization program for suppliers providing home infusion therapy (HIT) services and that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, CMS will publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January through March 2024
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM's) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data.
Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry (Revised); Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #120 entitled "Veterinary Feed Directive Regulation Questions and Answers." This revised guidance document will aid industry in complying with the requirements of the veterinary feed directive (VFD) regulation.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
